North Central Cancer Treatment Group to conduct phase II study

April 28, 2010

By Flinn Foundation

[Source: ] – Cell Therapeutics, Inc. today announced that the North Central Cancer Treatment Group plans to conduct a Phase II study of brostallicin in combination with cisplatin in patients with metastatic triple-negative breast cancer, defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. Additionally, the majority of breast cancers that are associated with the susceptibility mutation (BRCA1) are of the triple-negative type. BRCA1 is a tumor suppressor gene which, when mutated, is associated with the development of hereditary breast cancers. Changes in the BRCA1 status can make tumors rapidly acquire resistance to chemotherapy requiring development of new agents to effectively treat these patients. Brostallicin is a novel synthetic second-generation DNA minor groove binder with enhanced efficacy in the presence of the BRCA1 mutation and has demonstrated synergy in combination with cisplatin, an active therapeutic for this disease. Brostallicin has also demonstrated a unique ability to retain activity in tumors that are resistant to other cancer drugs (Mol Cancer Ther 2009; 8(7) July 2009; 1985-94). Women with mTNBC have very limited effective treatments and based on the novel mechanism of action of brostallicin and the recognized activity of cisplatin in this disease, the combination of the two agents will be explored by the NCCTG.